1. Field of the Invention
This invention relates to a stabilized, aqueous film-forming, antimicrobial composition, and more particularly, to such composition comprising hydrogen peroxide (H.sub.2 O.sub.2), polyvinylpyrrolidone (PVP), a polyol, and water.
2. Background of the Prior Art
Hydrogen peroxide is a well known antispectic which has been extensively employed in aqueous solution for the treatment of infectious processes in both human and veterinary topical therapy. The agent can be used in its original form after suitable dilution, or it can be derived from those solid compounds which form salts or additive compounds with hydrogen peroxide. Included among these are sodium perborate, sodium carbonate peroxide, sodium peroxyphosphate, urea peroxide, potassium persulfate, and others. When added to water, these compounds hydrolyze into hydrogen peroxide and the corresponding carrying salt.
Although extensively employed for treating all parts of the body, hydrogen peroxide has proved especially valuable for treating the mucous membranes of the oral cavity. Partly as a consequence of oxygen tissue metabolic and reparative requirements (by a mechanism which is not clearly understood), partly as a consequnce of its broad antibacterial effects against gram positive and gram negative cocci, bacillus and spirochetal forms as well as many varieties of yeasts and fungi, and partly because of its cleaning and hemostatic effects, hydrogen peroxide is extensively recommended and used for bacterial and viral infections and for tissue inflammations of non-microorganic origin.
The principal limitations of commonly used peroxide aqueous solutions, however, are their poor shelf stability caused by the decomposition of hydrogen peroxide into gaseous oxygen and water at room temperature, and the transitory contact of the active oxygenating agent with the affected tissue. In addition, when such compositions are formed of additive compounds with hydrogen peroxide, it is common to prepare the adduct composition before incorporating it into the desired composition.
The following U.S. Pat. Nos. are illustrative of the state of this art; 3,376,110; 3,480,557; 3,629,331; 3,657,413; 4,155,738; 4,302,441; 4,514,384; 4,518,583; 4,522,805; 4,528,180; 4,609,674; 4,826,681; 4,837,008; and 4,895,875.
However, these and other references of the prior art do not provide a stabilized, aqueous, film-forming antimicrobial composition of hydrogen peroxide which has an extended shelf-life with respect to decomposition into oxygen and water, an increased period of retention on tissues, and which can be formulated in situ from aqueous hydrogen peroxide, a stabilizing and film-forming agent, and a viscosity modifier.
Accordingly, it is among the objects of the present invention to provide an aqueous antimicrobial composition of hydrogen peroxide which has a stable shelf-life, is capable of being retained on oral tissue for extended periods of time, is a film-former on application to an infected tissue, and which can be formulated in situ from an aqueous hydrogen peroxide solution, a stabilizing, film-forming and complexing agent capable of complexing with hydrogen peroxide in a defined molar ratio, and a viscosity modifier in which the stabilizing agent can function effectively to provide the desired stabilized composition.
These and other objects and features of the invention will be made apparent from the following description thereof.